SAN DIEGO, CA and LEIDEN, THE NETHERLANDS -- (Marketwire) -- 11/07/12 -- Statistically
significant results for primary endpoint of time to beginning of symptom
relief

Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM)
today announced that their pivotal Phase III clinical study to evaluate the
safety and efficacy of the investigational drug RUCONEST® (recombinant
human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of
angioedema in patients with Hereditary Angioedema (HAE) met the primary
endpoint of time to beginning of
symptom relief.

A statistically significant difference in the time to beginning of symptom
relief was observed in the intent-to-treat population (n=75) between
RUCONEST
and placebo (p=0.031, log-rank test); the median time to beginning of
symptom
relief was 90 minutes for RUCONEST patients (n=44) and 152 minutes for
placebo
patients (n=31). The time to beginning of symptom relief was defined as
the
time from the beginning of infusion of study medication (RUCONEST or
placebo)
until the beginning of a persistent beneficial effect, based on the
patient's
responses to a Treatment Effect Questionnaire for the primary attack
location.

RUCONEST was generally well tolerated in this Phase III clinical study and
the
frequency of patients experiencing at least one treatment emergent adverse
event
in the RUCONEST treated group was less than in the placebo group. Within 72
hours of the completion of infusion of study medication, four RUCONEST
patients
(7%) experienced six adverse events: sneezing, procedural headache, back
pain,
skin burning sensation, an increase in fibrin D-dimer and lipoma. Within
the 72
hour period four placebo patients (22%) experienced four adverse events:
sinus
congestion, vasomotor rhinitis, diarrhea and dyspepsia. Thromboembolic
events,
anaphylaxis, or neutralizing antibodies to C1 inhibitor were not observed
in any
patient. There was one patient in the RUCONEST group that experienced a
serious
adverse event (abdominal hernia at Day 79) that was assessed by the
investigator
as not related to the study drug.

"These positive results are consistent with the efficacy data previously
reported from two smaller randomized, controlled clinical studies with
RUCONEST
in patients with HAE, and we believe the results provide strong support for
our
proposed dosing regimen of 50 U/kg in treating acute attacks of HAE," said
Wendell Wierenga, Ph.D., executive vice president of research and
development of
Santarus.

"We are very pleased with these pivotal study results and look forward to
working with our colleagues at Santarus to prepare and submit the Biologics
License Application (BLA) for RUCONEST to the FDA in the first half of
2013,"
said Bruno Giannetti, M.D., Ph.D., chief operations officer of Pharming.
"We
anticipate that additional data from this Phase III study will be presented
at
an appropriate medical meeting in 2013."

Santarus licensed exclusive rights to commercialize RUCONEST in North
America
for the treatment of acute attacks of HAE as well as other potential future
indications from Pharming. Under the terms of the license agreement, a $10
million milestone is now payable to Pharming as a result of the successful
achievement of the primary endpoint of the Phase III clinical study. An
additional $5 million milestone will be payable to Pharming upon U.S. Food
and
Drug Administration (FDA) acceptance of the BLA for review.

RUCONEST Phase III Clinical Study (Study 1310)

Pharming conducted Study 1310 with RUCONEST under a Special Protocol
Assessment
(SPA) agreement with the FDA, and the study is intended to support the
submission of a BLA in the U.S.

* In Study 1310, RUCONEST was evaluated for the treatment of acute
attacks of
angioedema in patients with HAE in an international, multicenter,
randomized, placebo-controlled Phase III study comparing a single IV
infusion of 50 U/kg of RUCONEST to a saline control with a primary
endpoint
of time to beginning of symptom relief.

* The time to beginning of symptom relief was defined as the time lapsed
from
the beginning of the infusion of study medication to the beginning of a
persistent beneficial effect based on the patient's responses to a
Treatment
Effect Questionnaire for the primary attack location.

* A 90 day follow-up period was required for each patient enrolled, or
until
such time that the patient required open-label treatment for a
subsequent
attack during the 90 day period. The data from the open-label
extension are
being collected for additional efficacy and safety analyses.

* The study enrolled a total of 75 patients who were randomized 3:2 to
receive
either RUCONEST or saline.

About RUCONEST and Hereditary Angioedema

RUCONEST (INN conestat alfa) is a recombinant version of the human protein
C1
esterase inhibitor, and is produced with Pharming's proprietary technology
which
uses milk from transgenic rabbits. RUCONEST is approved in Europe for the
treatment of acute angioedema attacks in patients with HAE, a genetic
disorder
in which the patient is deficient in or lacks a functional plasma protein
C1
esterase inhibitor, resulting in unpredictable and debilitating episodes of
intense swelling. The swelling may occur in one or more anatomical areas,
including the extremities, face, trunk, genitals, abdomen and upper airway.
The
frequency and severity of HAE attacks vary and are most serious when they
involve laryngeal edema, which can close the upper airway and cause death
by
asphyxiation. According to the U.S. Hereditary Angioedema Association,
epidemiological estimates for HAE range from one in 10,000 to one in 50,000
individuals. RUCONEST is an investigational drug in the U.S. and has been
granted orphan drug designation by the FDA both for the treatment of acute
attacks of HAE and for prophylactic treatment of HAE.

About Pharming Group NV

Pharming Group NV develops innovative products for the treatment of unmet
medical needs. RUCONEST® is a recombinant human C1 esterase inhibitor
approved
for the treatment of angioedema attacks in patients with HAE in all 27 EU
countries plus Norway, Iceland and Liechtenstein, and is distributed in the
EU
by Swedish Orphan Biovitrum (OMX: SOBI). The product is also being
evaluated for
various follow-on indications. Pharming's advanced technologies include
innovative and validated platforms for the production of protein
therapeutics,
technology and processes for the purification and formulation of these
products.
A feasibility study, using the validated transgenic rabbit platform, aimed
at
the development of recombinant Factor VIII for the treatment of Haemophilia
A is
underway with partner, Renova Life, Inc. Additional information is
available on
the Pharming website, www.pharming.com.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on
acquiring,
developing and commercializing proprietary products that address the needs
of
patients treated by physician specialists. The company's current
commercial
efforts are focused on GLUMETZA® (metformin hydrochloride extended
release
tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are
indicated
as adjuncts to diet and exercise to improve glycemic control in adults with
type
2 diabetes, and on FENOGLIDE® (fenofibrate) tablets, which is
indicated as an
adjunct to diet to reduce high cholesterol. Santarus also sells
ZEGERID®
(omeprazole/sodium bicarbonate), which is indicated for the treatment of
certain
gastrointestinal diseases and disorders.

Santarus has a diverse product development pipeline. A New Drug
Application for
UCERIS (budesonide) for induction of remission of active mild to
moderate
ulcerative colitis is under review by the U.S. Food and Drug Administration
with
a response expected in January 2013. The pipeline also includes two
late-stage
investigational drugs in Phase III clinical studies: RUCONEST®
(recombinant
human C1 esterase inhibitor) for treatment of acute attacks of hereditary
angioedema and rifamycin SV MMX® for treatment of travelers' diarrhea.
In
addition, the company's investigational monoclonal antibody, SAN-300, is
being
evaluated in a Phase I clinical program. More information about Santarus
is
available at www.santarus.com.

Santarus and Pharming caution you that statements included in this press
release
that are not a description of historical facts are forward-looking
statements.
The inclusion of forward-looking statements should not be regarded as a
representation by Santarus or Pharming that any of its plans or objectives
will
be achieved. Actual results may differ materially from those set forth in
this
release due to the risks and uncertainties inherent in Santarus and
Pharming's
businesses, including, without limitation: risks related to the timing for
submission of the BLA and whether the FDA will accept the BLA for review
following submission and ultimately approve it; whether the FDA will concur
with
the clinical interpretation of the Phase III study results or the conduct
of the
study; whether the FDA ultimately will require additional clinical studies
or
other development programs before accepting the RUCONEST BLA or approving
RUCONEST; risks related to Santarus' dependence on Pharming for many
functions
related to RUCONEST, and Pharming's ability to continue to perform these
functions based on its limited financial resources; risks related to the
license
and supply arrangements between Santarus and Pharming, including the
potential
for termination of the arrangements; other difficulties or delays in
development, testing, manufacturing and marketing of, and obtaining and
maintaining regulatory approvals for, Santarus' and Pharming's products;
and
other risks detailed in prior press releases as well as in public periodic
filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary statement and
neither Santarus nor Pharming undertakes any obligation to revise or update
this
news release to reflect events or circumstances after the date hereof.
This
caution is made under the safe harbor provisions of Section 21E of the
Private
Securities Litigation Reform Act of 1995.

Santarus®, FENOGLIDE®, UCERIS, and ZEGERID® are
trademarks of
Santarus, Inc. GLUMETZA® is a trademark of Biovail Laboratories
International
S.r.l. licensed exclusively in the United States to Depomed, Inc.
CYCLOSET®
is a trademark of VeroScience LLC. MMX® is a trademark of Cosmo
Technologies
Limited. RUCONEST® is a trademark of Pharming Group N.V.

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